Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-18 @ 5:16 AM
Study NCT ID:
NCT02164058
Status:
WITHDRAWN
Last Update Posted:
2015-12-04
First Post:
2014-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TandemHeart to Reduce Infarct Size (TRIS Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-03', 'studyFirstSubmitDate': '2014-06-12', 'studyFirstSubmitQcDate': '2014-06-12', 'lastUpdatePostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety', 'timeFrame': '30 days post-procedure', 'description': 'Major Adverse Cardiac or Cerebrovascular Events (MACCE):\n\n* Death, all cause\n* Stroke\n* Reinfarction\n* Major vascular complications'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myocardial infarction', 'STEMI', 'ST elevation MI', 'Acute MI'], 'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a device known as the TandemHeart® System (TandemHeart) can help limit heart damage and reduce serious complications after a certain type of heart attack (acute ST elevation anterior wall myocardial infarction \\[STEMI\\]) by evaluating the use of the TandemHeart system prior to a procedure called percutaneous coronary intervention (PCI)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\nThe following is a list of general inclusion criteria. More detailed information can be found in the study protocol.\n\n1. ≥ 18 years of age\n2. Presents within 6 hours of acute MI symptoms\n3. Evidence of ST elevation\n4. First myocardial infarction\n5. Written informed consent\n\nEXCLUSION CRITERIA\n\nThe following is a list of general exclusion criteria. More detailed information can be found in the study protocol.\n\n1. Contraindications to antiplatelet/anticoagulation therapy\n2. History of blood disorders or active bleeding\n3. Renal dysfunction or failure\n4. Neurologic damage\n5. Cardiogenic shock\n6. History of cerebrovascular disease\n7. History of transfusion reaction\n8. Prior coronary artery bypass surgery\n9. Participation in another trial with an investigational drug or device\n10. Pregnant'}, 'identificationModule': {'nctId': 'NCT02164058', 'acronym': 'TRIS', 'briefTitle': 'TandemHeart to Reduce Infarct Size (TRIS Trial)', 'organization': {'class': 'INDUSTRY', 'fullName': 'CardiacAssist, Inc.'}, 'officialTitle': 'A Randomized Controlled Multicenter Study on the Use of the TandemHeart to Reduce Infarct Size', 'orgStudyIdInfo': {'id': 'CA 2011-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TandemHeart System + PCI', 'description': 'TandemHeart System prior to percutaneous coronary intervention', 'interventionNames': ['Device: TandemHeart System', 'Procedure: Percutaneous coronary intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCI', 'description': 'Percutaneous coronary intervention', 'interventionNames': ['Procedure: Percutaneous coronary intervention']}], 'interventions': [{'name': 'TandemHeart System', 'type': 'DEVICE', 'armGroupLabels': ['TandemHeart System + PCI']}, {'name': 'Percutaneous coronary intervention', 'type': 'PROCEDURE', 'otherNames': ['PCI'], 'armGroupLabels': ['PCI', 'TandemHeart System + PCI']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CardiacAssist, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}